Events

Safety Alert Or Field Safety Notices for Bedside model 4170 serial numbers: 1 - 998

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by APC Medical Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/095
  • Event Number
    CON2033312
  • Date
    2007-12-06
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2033312
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off. following the investigation of a returned bedside model 4170 temporary cardiac pacemaker, the manufacturer has concluded that there is a potential for rapid pacing to occur when shutting off the device. this can only occur if there is a failure of a specific electronic component within the pacemaker box, and the rapid pace switch is left on. apc medical ltd issued an advisory notice on 09 november 2007 to all affected uk centres. the manufacturer has developed a software modification to eliminate the possibility of rapid pace pulses from occurring on shutdown. they have requested that all affected pacemakers are returned to them for appropriate upgrade. the temporary cardiac pacemaker can be used while awaiting upgrade provided the rapid pace switch is off when shutting down the device.
  • Action
    Check that the rapid pace switch is turned off before shutting down the device. Identify all pacemakers with serial numbers 1 - 998 and return to APC Medical Ltd for a software upgrade. Contact APC Medical Ltd customer service department for information on how to schedule the return of your device(s) for upgrade.

Device

Bedside model 4170 serial numbers: 1 - 998
  • Model / Serial
  • Product Description
    External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 - 998. Manufactured by APC Medical Ltd. The APC Bedside model 4170 single chamber external temporary cardiac pacemaker is designed in the USA by Pace Medical Inc., produced in the UK by APC Medical Ltd and supplied to UK hospitals by APC Cardiovascular.
  • Manufacturer
    APC Medical Ltd

Manufacturer

APC Medical Ltd